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Clinical Study on the Efficacy of Medical Anti-Allergic Nasal Gel in the Treatment of Allergic Rhinitis

Clinical Study on the Efficacy of Medical Anti-Allergic Nasal Gel in the Treatment of Allergic Rhinitis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110879
Enrollment
Unknown
Registered
2025-10-22
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergic rhinitis

Interventions

Placebo group:Placebo gel spray
Medical anti-allergic nasal gel group:Medical anti-allergic nasal gel

Sponsors

Shenzhen Nanshan People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18 - 60 years old (including boundary values), no gender restrictions; 2.Diagnosed with moderate-to-severe persistent allergic rhinitis (based on the 2022 "Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis"); 3.TNSS score: Each primary symptom >= 2 points; 4.After standardized anti-allergic drug treatment (including continuous local glucocorticoids, local and oral antihistamines, nasal irrigation, etc.), the therapeutic effect was poor, and the symptoms seriously affected the patient's life; 5.Voluntarily sign the informed consent form, understand and accept the duration of the study, be able and willing to comply with all requirements, including following the treatment plan, participating in follow-up visits, and other research procedures.

Exclusion criteria

Exclusion criteria: 1.Patients with allergic rhinitis combined with asthma; 2.Received anti-IgE treatment (omalizumab) and allergen-specific immunotherapy; 3.Suffering from other diseases of the nasal cavity and paranasal sinuses (such as nasal polyps, chronic rhinitis, chronic sinusitis, structural deformities of the framework, etc.); 4.Diagnosed with autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, etc. 5.Cases with severe systemic diseases such as tumors, digestive tract ulcers, diabetes, tuberculosis, mental disorders, etc. 6.Specific infections such as syphilis, leprosy, and tuberculosis; 7.Subjects who have been using immunosuppressants for a long time; 8.Women who are planning to conceive, are pregnant, or are breastfeeding; 9.The participants who have participated in other clinical trials in the past month; 10.The researchers considered that certain participants were not suitable for this clinical study.

Design outcomes

Primary

MeasureTime frame
Total nasal symptom score (TNSS);

Secondary

MeasureTime frame
The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score;Detection of interleukin 4 (IL-4) and eosinophils in nasal secretions;

Countries

China

Contacts

Public ContactLi Shuo

Shenzhen Nanshan People's Hospital

soccerlee22@163.com+86 755 2655 3111

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026